BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURRENT ACCEL DR, DF4 CONNECTOR

    MDR report key: 3791189 · Received May 5, 2014

    Report

    Report Number
    2938836-2014-10387
    Event Type
    Injury
    Date Received
    May 5, 2014
    Date of Event
    January 22, 2014
    Manufacturer
    ST. JUDE MEDICAL, INC., CRMD
    Product Code
    LWS
    PMA / PMN Number
    P910023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL INFORMATION PROVIDED BY MANUFACTURER, NO MEDWATCH FORM WAS RECEIVED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A ROUTINE FOLLOW-UP, DEVICE INTERROGATION REVEALED THAT THE PATIENT EXPERIENCED A VT EPISODE. SEVERAL ATP AND HIGH VOLTAGE THERAPIES WERE DELIVERED UNSUCCESSFULLY. THE PATIENT'S RHYTHM CONVERTED SPONTANEOUSLY. THE DEVICE WAS REPROGRAMMED AND THE ISSUE WAS RESOLVED. THE PATIENT WAS ASLEEP DURING THE EPISODE AND DID NOT REPORT ANY SYMPTOMS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    269336 CURRENT ACCEL DR, DF4 CONNECTOR IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LWS ST. JUDE MEDICAL, INC., CRMD CD2215-36Q NA

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention